Treating lymphangioleiomyomatosis with doxycycline

• Register: REBEC
• Last refreshed on: 29 April 2013
• Main ID: RBR-6g8yz9
• Date of registration: 29/03/2012
• Primary sponsor: Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo - Brazil
• Public title: Treating lymphangioleiomyomatosis with doxycycline
• Scientific title: Effects of doxycycline on radiological and functional assessment and metalloproteinase blockage in patients with lymphangioleiomyomatosis
• Date of first enrolment: 08/01/2011
• Target sample size: 30
• Recruitment status: data analysis completed
• URL: http://www.ensaiosclinicos.gov.br/rg/RBR-6g8yz9/
• Study design: Clinical trial, single-arm, non-randomized, open label, phase 2-3.

Countries of recruitment

Brazil

Contacts

• Name: SUZANA PIMENTA
• Affiliation: Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo

• Name: SUZANA PIMENTA
• Affiliation: Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo

Key inclusion & exclusion criteria

Inclusion criteria: Patients with an established clinical-radiological or histopathological diagnosis of lymphangioleiomyomatosis
Exclusion criteria: Patients submitted previously to lung transplant

Age minimum: 17Y
Age maximum: 90Y
Gender: F

Health Condition(s) or Problem(s) studied

Lymphangioleiomyomatosis, doxycycline, respiratory tract diseases
C04.557.375.460.465

Intervention(s)

31 female LAM patients have received doxycycline orally (100mg/day) for 6 months. They underwent evaluations at basal month and 6th month through pulmonary function tests, six-minute walk test (6MWT), quality of life assessment questionnaire (SF-36) and blood and urine samples for metalloproteinases MMP-2 e -9 dosage. No placebo.

Primary Outcome(s)

- Variation of urinary and serum metalloproteinase (MMP) -2 and -9 levels, after doxycycline treatment, according to the levels at the time of protocol´s admission.

- Variation of FEV1 (forced expiratory volume in the first second), obtained from the difference between FEV1 after 6 months with doxycycline and the basal FEV1.

Secondary Outcome(s)

- Lung volumes (total lung capacity and residual volume), carbon monoxide diffusion capacity and variables derivated from the six-minute walk test, such as distance walked and minimal oxyhemoglobine saturation before and after doxycycline.

- Variation of the Dessaturation- Distance Index, obtained from the ratio between desaturation area and the walked distance during six-minute walk test, after doxycicline

- Adverse events during the treatment with doxycicline

Secondary ID(s)

CAAE - 0293.0.015.000-07

Source(s) of Monetary Support

Conselho Nacional de Desenvolvimento Científico e Tecnológico (CNPq) - Brazil

Secondary Sponsor(s)

Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo - Brazil